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ACTOS Warning from Drugwatch.com

Drugwatch.com have supplied the following release about Actos (aka pioglitazone). 

Actos causes bladder cancer with prolonged use

Some health agencies recommend warning labels and others impose outright bans

Studies show a link between Actos and bladder cancer. While this news may seem like a bombshell for anyone with type-2 diabetes, it is not considered such overwhelming news for the U.S Food and Drug Administration (FDA).

And while it might seem like devastating news for drug maker Takeda Pharmaceuticals, it has not been so. The drug is banned in some countries but not in the United States.

Actos was developed in the 1990s and is used as a long-term therapy to reduce insulin resistance. Insulin resistance is a problem common among patients with type 2 diabetes.

But the FDA has said the use of Actos, also known as pioglitazone, for more than one year may be associated with an increased risk of bladder cancer. The drug regulators also ruled that these risks must be put on Actos labels.

In addition, several national associations have also released statements that seem to aim at minimizing patients’ reactions to these potentially fatal and disturbing study findings.

The Endocrine Society, the American Association of Clinical Endocrinologists, and the American Diabetes Association are just a few of the most vocal of these U.S. associations. These advocate groups have released the most content advising patients not to stop the use of Actos without the guidance of a doctor. They inform patients that doing so may cause serious blood glucose-related problems that may lead to health complications.

The problem is that, according to the studies, continuing to take Actos may have severe health risks as well.

Agencies in the United States have not recommended an all-out ban on Actos. But in Europe, the backlash from the Actos bladder cancer risk is being taken more seriously. After the French Public Health Insurance Office published its study findings in June 2011, France and Germany immediate imposed bans and sanctions on the prescription medication.

The published study revealed that patients taking Actos for 24 months or longer face an increased risk of developing bladder cancer. The risk was up to 50-percent higher than those who did not take the drug.

Health officials at the London-based European Medicine Agency (EMA) recommended that warning labels be added to the packaging of Actos and all related medications in order to alert health workers and patients to the bladder cancer risk. Actos is especially dangerous to patients who already have a history of or greater risk of cancer.

The FDA has also taken a similar action requiring that a “black box” warning be added to all Actos packages in the United States. The black box warning is only used then a prescription medication poses severe and potentially fatal health risks.  

The medication belongs to a class of drugs called thiazolidinediones (TZDs). Actos can be prescribed in three different strengths and in combination with other drugs like Metformin. Actos is taken orally in pill form usually once a day.

In addition to the more serious health risks such as bladder cancer, other, less severe, side-effects include:  headache, sinus infection, toothache, muscle pain, sore throat, water retention, fatigue, stomach cramps, jaundiced eyes, and appetite loss.

Concerned patients may visit the FDA's website for more information about Actos side effects and health risk warnings.

Further information can be found here http://www.drugwatch.com/actos/


Last updated by David May 8, 2012.



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